IND SUBMISSIONS MAY INCLUDE UNAUDITED INTEGRATED TOX SUMMARY -- FDA REFORMS; CLINICAL HOLD AUTHORITY LIMITED TO NEW DRUG REVIEW DIVISION DIRECTORS
Executive Summary
Sponsors would be allowed to use unaudited, integrated toxicology summaries in support of an IND submission for a drug or "well-characterized" biologic under one of three FDA reform proposals related to INDs. In a Nov. 21 "Talk Paper," the agency said it is issuing a guidance "which signals FDA's willingness to accept a summary report of toxicology findings based upon unaudited, draft toxicologic reports of completed studies."